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Tank, Holding, Dialysis
FDA product code FIN · Class 2 · Gastroenterology, Urology
58
Registered devices
5
Adverse events
4
Recalls
18
510(k) clearances
Devices with this code
PSDS Bicarb Systems — MAR COR PURIFICATION, INC.MCB Series — MAR COR PURIFICATION, INC.BICARB, DUAL, 100, MIX/DEL — BETTER WATER, LLCMCB Series — MAR COR PURIFICATION, INC.AmeriWater 00BCMD55 — AMERIWATER, LLCMCB Series — MAR COR PURIFICATION, INC.AmeriWater 0077-0010 Ozone Disinfection System — AMERIWATER, LLCSDS Bicarb Systems — MAR COR PURIFICATION, INC.SDS Bicarb Systems — MAR COR PURIFICATION, INC.BICARB, SINGLE, 60, MIX/DEL — BETTER WATER, LLCMCB Series — MAR COR PURIFICATION, INC.AmeriWater 00BC100-100 Bicarb Mix and Distribution System — AMERIWATER, LLCBICARB, DUAL, 100, MIX/DEL/1000, SP — BETTER WATER, LLCSDS Bicarb Systems — MAR COR PURIFICATION, INC.RUSCH — TELEFLEX INCORPORATEDAmeriWater 00BC55-55 Bicarb Mix and Distribution System — AMERIWATER, LLCSDS Bicarb Systems — MAR COR PURIFICATION, INC.MCB Series — MAR COR PURIFICATION, INC.SDS Bicarb Systems — MAR COR PURIFICATION, INC.SDS Bicarb Systems — MAR COR PURIFICATION, INC.PSDS Bicarb Systems — MAR COR PURIFICATION, INC.SDS Bicarb Systems — MAR COR PURIFICATION, INC.PSDS Bicarb Systems — MAR COR PURIFICATION, INC.SDS Bicarb Systems — MAR COR PURIFICATION, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-28 | Isopure Corp | Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some o |
| 2019-04-19 | Isopure Corp | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause un |
| 2012-03-26 | Tango3 LLC | During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modification |
| 2006-11-12 | Hill-Rom, Inc. | False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling |
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